Compact-size, cost-effective, pre-configured full GMP washing machine
DS Optima – Pharma Grade Parts Washer is designed for validatable cleaning and optimal throughput of materials and components used in Bio-Pharmaceutical manufacturing in the smallest available footprint of valuable GMP manufacturing space.
The design ensures self-cleaning of the machine chamber and pipework at each process stage, to prevent cross contamination risk. It can be configured in different layout: single or passthrough double door version with hinged full glass door. The technical area can be on right or left side. The heating elements, located in the sump, are pharma industry compliant, sanitary and dead leg free, fabricated from AISI 316L (1.4404) stainless steel and electro-polished. They may be connected to plant steam in the Steam heat exchanger version or directly to plant power in the Electrical heat exchanger version.
Drying phase assure the complete drying of the items loaded into washing chamber, both internal and external surface. The electrical heating elements enable variable drying temperature control. The HEPA filter is placed in line at the end of the drying path before entering the chamber and rack.
DS Optima PH is designed, manufactured, validated, and documented according to the latest global practices and standards to facilitate customer compliance with current Good Manufacturing Practices (cGMP’s).
Key features of GMP washer from Steelco
Compact-size & cost-effective GMP washer
- A compact-size, cost-effective washer with standard features and some available options in order to enable a very rapid process from the order to delivery.
Unrivalled performance
- Thanks to a state-of-the-art hydraulic design, the device guarantees repeatable and validatable washing results with minimum water and energy consumption.
Drying efficacy
- The drying unit enables variable drying temperature control, ensuring time reduction and excellent results. The HEPA filter is placed in line at the end of the drying path before entering the chamber and rack.
Remote assistance
- The on-board VPN router communicates on the local network with the PLC and the HMI and allows remote connection from a computer, tablet, or smartphone without going on-site, drastically reducing support costs and improving machine uptime.
Easy maintenance
- The machine is developed considering technicians’ access to the maintenance and service area – easy access to all components and electrical cabinet from the loading side.
Non-Proprietary Parts
- Only proven, non-proprietary, globally available components and automation systems. Steelco provides full details of every component allowing customers to source spare parts either from Steelco or from the original equipment manufacturer.
3 months ready for FAT!
A fast-track development of a pre-configured fully GMP compliant washing machine for the pharmaceutical manufacturing industry. A compact-size, cost effective GMP washer with standard features and available options to enable minimal lead time from order to delivery.
Reliable and hygienic construction
The large 1200 liters washing chamber and the hydraulic system are designed and constructed with extreme care and have a surface finish with a roughness average of Ra<0.51 μm / 20μin (Ra<0.38 μm / 15μin available upon request). All wetted surfaces are crevice-free construction, with orbital welding for piping to eliminate water retention and stagnation points where biofilm could accumulate. AISI 316L stainless steel is used internally with EPDM, PTFE, or other FDA-approved (21CFR part 177) material gaskets. The chamber features angled surfaces and rounded corners to ensure complete drainage. Detailed engineering on the sump reduces water consumption and assures high performance in terms of both cleaning and consumption. Multiple sanitary rotating washing arms are located on the top and on the bottom of the chamber to provide full washing and drying coverage for the items being processed, as well as the chamber.
Cycle development
Steelco DS Optima PH can run different cycle recipes, selectable from the operator panel. Each recipe is a combination of the following phases with adjustable setpoints and durations:
- Pre-wash
- Wash with or without detergent(s)
- Rinse with or without recirculation
- Recirculated or single-pass.
- Drying
- Cooling
- In-between above steps, air purging of process piping is available to avoid any risk of cross-contamination
All standard or custom cycle recipes are analyzed and identified during the design phase, according to the items to be cleaned.
Easy access to sampling and dosing system
A sampling of process media is a key Quality Assurance requirement in any pharmaceutical cleaning process and cleaning validation procedure. DS Optima PH can be equipped with different sampling systems provided of the manual or automatic valves to meet the most rigorous requirements:
- Water sampling from the sump
- Water sampling from the final rinse system
- Water sampling from the point of use for each water
Easy access to the sampling system and chemical storage from the technical service area located below the chamber on the loading side.
Integrated Automation Architectures
Steelco DS Optima PH is equipped with a user-friendly control system 15″ color touch screen HMI (on loading side) developed according to the latest ISPE GAMP© Guidelines and designed for FDA 21 CFR Part 11 and EU Annex 11 compliance. System platforms available include Siemens or Rockwell/Allen-Bradley. Irrespective of the platform, all Steelco Pharma equipment (washers, autoclaves, etc) has a common look and feel, consistent interface, and common GMP data management. Dependent on client policy, Steelco offers remote access via a virtual private network (VPN) to provide support during start-up, qualification, and maintenance activities.
Customized rack configurations
Steelco designs, develops, manufactures, and tests its own racks and trolleys in-house, ensuring that this critical process’ quality attribute is assured and providing a single point of responsibility for the design and function of the entire cleaning process. Steelco’s engineering experience and sophisticated 3D CAD programs provide that every point, corner, and cavity of an item to be processed is deeply and efficiently cleaned, thus avoiding the possibility of cross-contamination and eliminating all soil and contaminant residues from the previous process. The same injection porting is used to also convey hot sterile filtered air inside each cavity for effective drying.
Steelco pharma grade machines comply with the applicable requirements of the following regulations and industry accepted guidelines:
- cGMP
- GAMP 5
- FDA Regulation 21 CFR Part 11, 211, 820
- Eudralex
- ASME BPE
- PDA Technical Report
- European and US Pharmacopeia
- ISPE Guidelines
- UL and CSA (on demand)
Dimensions of compact-size, cost-effective, pre-configured full GMP washing machine:
- Chamber volume: 1200 liters
- Chamber dimensions WxDxH: 1000 x 1000 x 1200 mm
- Overall dimensions WxDxH: 2200 x 1150 x 2500 mm